NCT05223374Completed
Extension for Community Healthcare Outcomes (ECHO) Autism Diagnostic Study in Primary Care Setting
Source: ClinicalTrials.gov · Last updated 8 Feb 2024
Brief summary (registry, in English)
This is a collaborative study that will provide a comprehensive source of observational data that can be used to obtain real world evidence of ASD. The study will contain demographic and observational clinical data for eligible participants. All decisions regarding patient care will be determined by the ECHO Autism Clinician (EAC). All clinical outcomes will be assessed by the EAC as would occur in routine clinical practice.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 110 (actual)
- First submitted
- 20 Jan 2022
- Start date
- 1 Mar 2022
- Primary completion date
- 4 Feb 2024
- Lead sponsor
- Cognoa, Inc.
- Diseases
- Autism
- NCT number
- NCT05223374
What you commit to
- Study type: Observational
- Participants enrolled: 110
- From 1 Mar 2022 to the primary completion date, 4 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants with a prior diagnosis of Autism Spectrum Disorder (ASD) rendered by a healthcare professional
- Participants or caregivers who have, to the best of their knowledge, been previously enrolled in any Cognoa clinical study or survey
Other illness
- Participants with any other medical, behavioral, or developmental condition that in the opinion of the ECHO Autism Clinician may confound study data/assessments
Age
- Participants whose age on the date of enrollment is outside the target age range
Who the study is looking for
- English is spoken proficiently by the participating patient/family, in the opinion of the EAC.
- Meets labeling of device
- Parent, guardian, or legally authorized representative (LAR) must be able to read, understand, and sign and date the Informed Consent Form (ICF)
- Sex assigned at birth (Female or male or non-binary)
- Female or male, \> 18 to \< 72 months of age
- Caregiver, HCP or community-based professional concern for developmental delay or Autism
- Parent/guardian/LAR must have smartphone utilizing the most recent and previous version of iOS and Android operating systems (iOS 13 or 14; Android 10 or 11, excluding Android Go)
- Participants must be willing to be videotaped as part of the device input
Age in the registry: 18 months to 72 months · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ECHO Autism Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.